WHO Issues Updated Nitrosamine Control Guidelines in TRS 1060 Annex 2

In April 2025, the World Health Organization (WHO) released TRS 1060, featuring updated guidance on nitrosamine control in pharmaceuticals, available now on the WHO website. Annex 2 of this series, titled "WHO Good Practice Considerations for the Prevention and Control of Nitrosamines in Pharmaceutical Products", provides essential recommendations for manufacturers, packagers, and suppliers of excipients, APIs, processing aids, and finished products.

This Annex supplements existing GMP and regulatory frameworks like ICH M7 (R2). It covers key areas such as risk assessment, root cause analysis, risk control strategies, and analytical testing. Chapters address sources of contamination including amines, nitrites, solvents, water, packaging, and environmental air. Importantly, it outlines interim acceptable intake limits for various nitrosamines and highlights practical steps for industry-wide implementation.

Manufacturers are encouraged to align processes with these latest guidelines to ensure product safety and regulatory compliance in mitigating nitrosamine risks.

01-08-2025